FDA Approves Amgen's Repatha Cholesterol Drug
August 27 2015 - 6:40PM
Dow Jones News
By Jonathan D. Rockoff
The Food and Drug Administration approved a new Amgen Inc.
cholesterol-lowering drug on Thursday, teeing up a rivalry with a
similar treatment that was approved just weeks earlier.
The Amgen therapy, Repatha, belongs to a powerful new drug class
that promises help for patients who have struggled to control their
cholesterol using older statin medicines. In July, the FDA approved
the first drug of this new class, Praluent, from Sanofi SA and
Regeneron Pharmaceuticals Inc.
Doctors and patients have been looking forward to these new
cholesterol-lowering agents, which are injections either monthly or
every two weeks. Some 11 million people in the U.S. can't lower
their so-called bad cholesterol, LDLs, to healthy levels using
statins pills like Lipitor and Crestor, according to Amgen.
"Many patients who are in a state where they cannot get to an
acceptable LDL level will benefit," Amgen R&D chief Sean Harper
said.
Yet health insurers and drug-benefit managers have expressed
concerns about the new drugs' cost. Analysts say the new drug class
could reach yearly sales of $10 billion world-wide.
As it did with Praluent, the FDA approved Repatha for use, in
addition to statin drugs, in patients with a hereditary condition
called familial hypercholesterolemia or with coronary-artery
disease that requires additional lowering of cholesterol.
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(END) Dow Jones Newswires
August 27, 2015 18:25 ET (22:25 GMT)
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